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Background: Local pharmaceutical production has been endorsed by the WHO as a means of addressing health priorities of developing countries. However, local producers of essential medicines must comply with international pharmaceutical standards in order to be eligible to compete in donor tenders. These standards determine production rights for on-patent and off-patent medicines, and guide international procurement of medicines. We reviewed the literature on the impact of Good Manufacturing Practice (GMP) on local production; a gap analysis from the literature review indicated a need for further research. Over sixty interviews were conducted with people involved in the Nepali pharmaceutical production and distribution chain from 2006 to 2009 on the GMP areas of relevance: regulatory capacity, staffing, funding and training, resourcing of GMP, inspectors' interpretation of the rules and compliance. Results: Although Nepal producers have increased their overall share of the domestic market, only the public manufacturer, Royal Drugs, focuses on medicines for public health programmes; private producers engage mainly in brand competition for private markets, not essential medicines. Nepali regulators and producers state that implementation of GMP standards is hindered by low regulatory capacity, insufficient training of staff in the industry, financial constraints and lack of investment for upgrading capital. The transition period to mandatory compliance with WHO GMP rules is lengthy. Less than half of private producers had WHO GMP in 2013. Producers are not directly affected by international harmonisation of standards as they do not export medicines and the Nepali regulator does not enforce the WHO standards strictly. Without an international GMP certificate they cannot tender for donor dependent health programmes. Conclusions: In Nepal, local private manufacturers focus mainly on brand competition for private consumption not essential medicines, the government preferentially procures essential medicines from the only public producer while donor funded programmes rely on international manufacturers compliant with international GMP standards. We also found evidence of private hospitals bypassing national medicines approvals process. Policies in support of local pharmaceutical production in developing countries as a source of essential medicines need to examine carefully how GMP regulations impact on regulators, local industry and production of essential medicines in practice. [ABSTRACT FROM AUTHOR]

Trade ministries from the World Trade Organization's (WTO's) 144 member states are presently deciding which public services to open to foreign competition under the complex liberalisation rules of the general agreement on trade in services (GATS). A frequent criticism of the WTO system is that it reduces national autonomy over public policy. However, respect for national sovereignty is asserted in the GATS treaty. Here, we examine claims made by the WTO and others that GATS exempts public services and does not require their privatisation. We discuss trade treaty processes that can subject public services to commercial rules, the treaty's flexibility with respect to national autonomy, and the effect of GATS in situations in which national autonomy is not protected. We conclude that national autonomy over health policy is not preserved under GATS, and that accordingly, there is a role for international standards that protect public services from the adverse effect of trade and market forces. [ABSTRACT FROM AUTHOR]

Discusses a decision by the United Kingdom's Competition Commission that could make all contracting out and commissioning of health care by N.H.S. and social services subject to European Union competition law, rather than a matter for national public health policy. Tensions between the European Union's economic constitution and national control over healthcare policy because of healthcare reforms; Judgment by the United Kingdom tribunal that shows how the courts are moving the dividing line between economic and social activities; Implications of the judgment.